NCT06611163进行中（未招募）3 期
A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Subcutaneous Tildrakizumab in Subjects With Moderate to Severe Genital Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 206
- 试验地点
- 57
- 主要终点
- Proportion of subjects with modified sPGA-G score of clear (0) or almost clear (1) with at-least a 2-point reduction from baseline
研究概览
简要总结
Phase 3 study to evaluate the efficacy and safety of subcutaneous Tildrakizumab in subjects with moderate to severe genital psoriasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol, and provide written informed consent in accordance with institutional and regulatory guidelines
- •Age ≥ 18 years of age at the time of signing consent
- •Diagnosis of moderate to severe psoriasis of the genital area at Screening and baseline defined as modified sPGA-G score of ≥
- •Presence of non-genital plaque psoriasis (BSA ≥1%) at both Screening and Baseline.
- •Presence of psoriasis of the genital area that is inadequately controlled with topical therapy or the subject is intolerant to topical therapy
- •Negative evaluation for TB within 4 weeks before initiating IMP, defined as a negative QuantiFERON test. Subjects with a positive QuantiFERON test or 2 successive indeterminate
- •QuantiFERON tests are allowed if they have all of the following:
- •no history of active tuberculosis (TB) or symptoms of TB,
- •a posteroanterior chest radiograph (with associated report available at the site) performed within 3 months of Screening with no evidence of active TB (or of any other pulmonary infectious diseases),
- •if prior latent TB infection, must have history of adequate prophylaxis (per local standard of care),
- •if presence of latent TB is established, then treatment according to local country guidelines must have been followed for 4 weeks, prior to dosing in the study at Visit 2-Week
- •A maximum of 2 QuantiFERON tests of no more than 3 weeks apart are allowed. A re-test is only permitted if the first is indeterminate; the result of the second test will then be used
排除标准
- •Predominantly non-plaque forms of psoriasis specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new-onset guttate psoriasis.
- •Planned surgical intervention between Baseline and the Week 16 evaluation for a pre-treatment condition.
- •Active infection or history of infections as follows:
- •any active infection (bacterial, fungal or viral) for which systemic anti-infectives were used within 28 days prior to first investigational medicinal product (IMP) dose, with the last dose having been received within 7 days of Screening,
- •a serious infection, defined as requiring hospitalization or intravenous (IV) anti-infectives within 8 weeks prior to the first IMP dose, with the last dose having been received within 7 days of Screening,
- •recurrent or chronic infections, e.g., chronic pyelonephritis, chronic osteomyelitis, bronchiectasis, or other active infection that, in the opinion of the Investigator, might cause participation in this study to be detrimental to the subject.
- •Any concurrent medical condition or uncontrolled, clinically significant systemic disease ( e.g., renal failure, heart failure, hypertension, liver disease, diabetes, or anemia) that, in the opinion of the Investigator, could jeopardize subject safety or compliance with the protocol.
研究组 & 干预措施
Tildrakizumab 100 mg
Experimental
Participants will receive Tildrakizumab 100 milligrams (mg) subcutaneous (SC) injection on Day 1, Week 4 and every 12 weeks thereafter until the end of treatment.
干预措施: Tildrakizumab 100 mg (Drug)
Placebo
Placebo Comparator
Participants will receive placebo SC injection at Day 1 and Week 4. Participants initially randomized to placebo will be switched to receive Tildrakizumab 100 mg at Week 16, week 20 and every 12 weeks thereafter until the end of treatment.
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of subjects with modified sPGA-G score of clear (0) or almost clear (1) with at-least a 2-point reduction from baseline
时间窗: Week 16
sPGA-G scale is a 6-point numerical scale that ranges from 0 (clear) to 5 (very severe)
Proportion of subjects with a modified sPGA-G score of clear (0) or minimal (1) with at-least a 2- point reduction from baseline
时间窗: Week 16
The modified sPGA-G is a 5-point scale ranging from clear (0), almost clear (1), mild (2), moderate (3), to severe (4) and incorporates an assessment of the severity of the three primary signs of the disease: erythema, elevation, and scaling. Higher scores indicate greater disease severity.
次要结局
- Proportion of subjects, with a baseline score of ≥ 4, who achieve at-least 4-point improvement in weekly average genital psoriasis itch numerical rating scale [GPI-NRS] within the GPSS for subjects(Week 16)
- Mean change from baseline in the affected Body Surface Area (BSA)(Week 16)
- Change from baseline in genital psoriasis symptoms scale [GPSS] total score and individual items scores(Week 16)
- Proportion of subjects with psoriasis area and severity index [PASI] 75 response(Week 16)
- Proportion of subjects with PASI 90 response(Week 16)
- Proportion of subjects with PASI 100 response, in subjects with BSA <10%(Week 16)
研究者
研究点 (57)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety Study of Tildrakizumab in the Treatment of Nail PsoriasisChronic Plaque PsoriasisModerate to Severe Nail PsoriasisNCT03897075Sun Pharmaceutical Industries Limited99
已完成
3 期
An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)Ulcerative ColitisNCT03518086Eli Lilly and Company1,281
已完成
3 期
A Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222) in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Followed by a Long-term Extension Study (MK-3222-011)Plaque PsoriasisNCT01729754Sun Pharmaceutical Industries Limited1,090
已完成
3 期
A Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis SuppurativaHidradenitis SuppurativaNCT06411899MoonLake Immunotherapeutics AG422
已完成
3 期
Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis SuppurativaHidradenitis SuppurativaNCT06411379MoonLake Immunotherapeutics AG418